MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Catalog Number PCDB1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Necrosis (1971); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent removal surgery and recurrent incisional ventral hernia repair surgery on (b)(6) 2015 and mesh was implanted during which the surgeon noted ¿the previously placed mesh was not attached to the right side of the fascia.The surgeon documented edematous bowel and ascites.He took down adhesions, removed the old mesh, and repaired the recurrence.¿ it was reported that the patient underwent debridement of scar tissue and removal of a suture on (b)(6) 2015 during which the surgeon noted ¿purulent fluid and dense fat necrosis.He excised the fat necrosis and debrided suture material as well as dense fibrotic tissue.¿ it was reported that the patient underwent incision and drainage of complex surgical wound infection on (b)(6) 2015 during which the surgeon noted ¿abscess cavity, which he suctioned and irrigated.¿ it was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted ¿two or three areas that were denuded and the mesh was exposed into the open wound cavity.The surgeon lysed the adhesions, excised the mesh and debrided the wound.A fistula tract was debrided as well.¿ it was reported that the patient experienced severe pain, diarrhea, discomfort and numbness.The patient had a previous mesh implanted on (b)(6) 2014 which is captured in separate file.No additional information is provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9659886
• MDR Text Key: 177934396
• Report Number: 2210968-2020-00875
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PCDB1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention